Tag: lymphoma

New Clinical Trial: A Phase 1/2 Study to Assess the Safety & Tolerability of Durvalumab as Monotherapy & in Combination Therapy in Subjects with Lymphoma or CLL

The Weill Cornell Medicine Lymphoma Program has recently opened a new clinical trial for men and women with relapsed/refractory lymphoma or relapsed/refractory chronic lymphocytic leukemia (CLL). The study sponsor is Celgene International, and the principal investigator at Weill Cornell is Jia Ruan, M.D., Ph.D. For more information about the study, please call Catherine Babaran, RN at 212-746-2651 or e-mail Catherine at cmb9017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 years and older.
  • Patients with relapsed/refractory lymphoma or relapsed/refractory CLL previously treated with at least one systemic therapy.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary

This clinical trial is for men and women with relapsed/refractory lymphoma or relapsed/refractory chronic lymphocytic leukemia (CLL) previously treated with at least one systemic therapy.

The purpose of this study is to test the safety and effectiveness, as well as to define the appropriate dose and schedule of an investigational drug and investigational combinations of drugs. Durvalumab is an antibody (a protein that works with your immune system) that attaches to a molecule known as “programmed-cell-death ligand 1” (PD-L1). Signals from PD-L1 help cancers avoid detection by the immune system. Durvalumab blocks these signals, interfering with the cancer’s ability to escape the immune system.

The study will consist of 3 parts: dose findings, dose confirmation, and dose expansion. Four treatment arms will be investigated:

  • Arm A (durvalumab plus lenalidomide and ritxuimab)
  • Arm B (durvalumab plus ibrutinib)
  • Arm C (durvalumab plus bendamustine and rituximab)
  • Arm D (durvalumab monotherapy)

Study subjects will receive treatment for approximately one year and be in follow-up for anywhere from two to five years after treatment.

During each 28-day treatment cycle, subjects will receive durvalumab infusion on Day 1 of Cycles 1 through 13 at a fixed dose of 1500 mg every 4 weeks in combination with:

  • Arm A: Lenalidomide orally once daily on Days 1 to 21 of each cycle for 12 months or until disease progression plus rituximab infusion on Days 2, 8, 15 and 22 of Cycle 1 and on Day 1 of Cycles 2 through 5.
  • Arm B: Ibrutinib continuous, once daily until disease progression.
  • Arm C: Bendamustine infusion on Days 1 and 2 of Cycles 1 through 6 plus rituximab infusion on Day 2 of Cycles 1 through 6.
  • Arm D: Durvalumab monotherapy arm.

Unmasking a Killer: How Immunotherapy Helps Your Body Find Cancer and Destroy It

One of the difficulties in treating all cancers is the inability of a person’s immune system to target cancer cells because of the cancer cells ability to avoid detection. Researchers throughout the Meyer Cancer Center at Weill Cornell Medicine and NewYork-Presbyterian have been researching new ways to help the immune system find these cancer cells. This field of research is known as immunotherapy. Immunotherapy is a type of biological therapy that helps the immune system fight cancer through the use of substances in the living organism. You can find more information and an explanation as to how immunotherapy fights cancer in the below video:

http://www.nyp.org/cancerunmasked/

While specific immunotherapy derived treatments are still in the clinical trial phase for lymphoma this is an area of active research. In this video Lymphoma Program Director, Dr. John P. Leonard refers to the development of immune checkpoint inhibitors as an, “…important new frontier…” in the treatment of lymphoma. Currently clinicals for lymphoma related immunotherapy are ongoing. Available trials for immunotherapy at Weill Cornell can be found on the Joint Clinical Trials website.

World Health Organization Says Herbicide May Cause Non-Hodgkin Lmyphoma

Glysophosate is a herbicide with the highest production volume of all herbicides. In the United States it is currently marketed under the trade name Roundup, and use has increased with the introduction of genetically modified crops resistant to glysophosate. Recently experts from the International Agency for Research on Cancer of the World Health Organization met and assessed the carcinogenicity of different herbicides. In glysophosate they found an increased risk for non-Hodgkin lymphoma:

Case-control studies of occupational exposure in the USA,14 Canada,6 and Sweden7 reported increased risks for non-Hodgkin lymphoma that persisted after adjustment for other pesticides. The AHS cohort did not show a significantly increased risk of non-Hodgkin lymphoma. In male CD-1 mice, glyphosate induced a positive trend in the incidence of a rare tumour, renal tubule carcinoma. A second study reported a positive trend for haemangiosarcoma in male mice.15 Glyphosate increased pancreatic islet-cell adenoma in male rats in two studies. A glyphosate formulation promoted skin tumours in an initiation-promotion study in mice.

Glyphosate has been detected in the blood and urine of agricultural workers, indicating absorption…Glyphosate and glyphosate formulations induced DNA and chromosomal damage in mammals, and in human and animal cells in vitro. One study reported increases in blood markers of chromosomal damage (micronuclei) in residents of several communities after spraying of glyphosate formulations.16 Bacterial mutagenesis tests were negative. Glyphosate, glyphosate formulations, and AMPA induced oxidative stress in rodents and in vitro. The Working Group classified glyphosate as “probably carcinogenic to humans”.

We will continue to follow this story as more information becomes available and update guidelines accordingly.